Members asked for label to identify device as surgical implant

SILVER SPRING, Md. -- A controversial implant for sterilizing women should clearly state that it's a surgical device and should come with more comprehensive instructions for insertion and follow-up monitoring, members of an FDA advisory committee said Thursday.

After a longer-than-usual discussion of post-marketing data, peer-reviewed studies, and hours of patient comments about the Essure device, the agency's Obstetrics and Gynecology Devices panel offered suggestions for best practices, stronger patient education, and increased collection of data. These included:

Developing a protocol that includes interoperative imaging to ensure correct device placement

Establishing guidance for practitioners to be able to identify long-term complications earlier

Supporting early intervention analysis if abnormal bleeding occurs following the procedure

Requiring a checklist or signed informed consent form to ensure clinicians discuss risks, benefits, and alternatives

Developing a patient registry for tracking the rate of pregnancies and adverse events

Strengthening training programs for device implantation and placement

Developing training around removal

Members also recommended changing the label language to indicate that the implantation is a "surgical" rather than "nonsurgical" procedure, as currently stated.

As well, panelists suggested stronger guidelines to allow clinicians to "give up" when a procedure becomes difficult -- for example, when a device won't move forward easily or when visualization is unclear.

The procedure may be more dangerous for the small percentage of women whose fallopian tubes are not "straight shots" but "tortuous," said Charles Coddington III, MD, a gynecological surgeon at the Mayo Clinic in Rochester, Minn.

The Essure system, developed by California-based Conceptus (now a Bayer Health subsidiary), approved in 2002 as a minimally invasive implant procedure, consists of an expandable nickel-titanium coil with a stainless steel coil inside it. After insertion, the device "conforms" to the fallopian tube, and triggers tissue growth that prevents sperm from entering the ducts.

After the procedure, women are instructed to continue using alternative contraception methods, until their clinician can confirm at 3 months that their fallopian tubes are entirely blocked, using a modified hysterosalpingogram. The FDA recently approved transvaginal ultrasound as an alternative confirmatory test. Women are urged not to stop using alternative contraception until occlusion has been confirmed.

However, an estimated 5,093 medical device reports -- indicating adverse effects in women receiving the device -- had been filed with the FDA as of June 1, 2015, according to agency briefing documents. An unusually large proportion of recent reports were submitted voluntarily by patients as opposed to the manufacturer, FDA staff indicated.

Panel Discussion

Regarding Essure's benefit-risk profile, Cheryl Iglesia, MD, temporary committee chair and surgeon at MedStar Washington Hospital Center, summarized panel members' consensus that the device was appropriate for patients who wanted permanent contraception and who had thoroughly discussed the device's advantages and potential harms with their clinician.

Favorable patient candidates might also include those at high risk to undergo general anesthesia or laparoscopy, or who may be obese, or who have failed other reversible forms of contraception, she added.

Patients with chronic pelvic pain, auto-immune disorders, hypersensitivity to nickel or other metals, pelvic inflammatory diseases, or a history of abnormal uterine bleeding, may not be well-suited to this device, she noted.

The committee's consumer representative, Cynthia Chauhan, MSW, from Wichita, Kan., also garnered committee support for her suggestion to mitigate risk by preparing for possible negative outcomes. "If you do not have access to someone who can remove [the insert] successfully you should not be implanting [it]," she said.

The committee also supported better monitoring and earlier removal of the device when problems are identified.

In addition to a patient registry, the committee urged increased data collection, specifically around allergies to device components. This might include biopsies of the tissues surrounding the device after removal and animal studies.

The possibility of a randomized controlled trial was considered but quickly dismissed by most panelists. Besides being expensive, such a trial would probably lack the statistical power to detect the sought-after events, said Marsha Wills-Karp, PhD, of the Bloomberg School of Public Health at Johns Hopkins University in Baltimore.

Richard Chappell, PhD, of the University of Wisconsin, in Madison, Wis., noted another practical issue: trying to convince patients to join a trial developed to answer questions around adverse events and efficacy. "I don't think it would accrue," he noted.

But Chappell criticized the FDA for approving the device without requiring a randomized trial in the first place. "It was a mistake not to have done so."

Patients, Others Weigh In

During the public portion of the discussion, more than 30 patients spoke, describing severe abdominal pain, bleeding irregularities, migraines, painful sex, auto-immune disorders, extreme fatigue, psoriasis, perforation of the uterus, and even narcolepsy and cataplexy -- all symptoms they attribute to the implantation of the Essure System. Some also noted that they became pregnant despite receiving the device.

Rebecca Howell, of Jacksonville, Fla., said she had the product implanted in 2011. Afterward, she suffered from back pain, migraines, heavy painful periods, hair loss, chronic fatigue, and nickel sensitivity. She grew depressed, even suicidal.

"I felt like less of a woman, less of a human," she said.

Many said they struggled to find clinicians willing to remove the implanted inserts -- but when they did, most of their symptoms dissipated.

Sarah Sorscher JD, MPH, of the consumer group Public Citizen's Health Research Group, told the committee, "A device that causes this level of long-term debilitating pain should not remain on the market."

Other patients and their advocates, such as Diana Zuckerman, PHD, president of the National Center for Health Research, accused the sponsor of manipulating survey questions and even rewriting patient responses.

"The question is do you believe what the data are showing or do you believe what the women are telling us," Zuckerman asked the committee.

An audit conducted by the FDA of sporadic cases from multiple sites concluded "that there was not a pattern of discordant reporting," according to an agency representative at the meeting.

The device did have some advocates. Roxanne Jamshidi, MPH, MD, a professor at George Washington University who spoke on behalf of the American Congress of Obstetricians and Gynecologists, said it's critical for women to have choices of different contraception.

Jamshidi requested more data on safety and efficacy, including the development of a comprehensive patient registry. "We want to understand the positive and negative impacts of this choice."

Planned Parenthood also expressed support for keeping Essure available as a contraceptive option "after adequate counseling."

In a press release, Bayer said it looked forward to working with the FDA as it considers the panel's recommendations.

"We remain committed to maintaining an open dialogue with any patient, advocate, or physician who has questions or concerns about Essure," it said.

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